Stuff You Should Know – Does the FDA Protect Americans?



hey and welcome to the podcast I'm josh Clark with Charles W Chuck Bryant and Jerry over there so this is stuff you should know the podcast how does your doing fine how are you great yeah yeah that's good I enjoyed learning about the FDA yeah you know we've podcast it on him before why doesn't the FDA regulate herbal supplements right man we did that long time ago remember that's where the herbal Elvis comes out oh yeah who's that the first appear it's pretty sure hey man give me some supplements yeah your dad doc yeah he just like would go around the house yeah when he was honorable up or sure yeah yeah man how'd he talk on the herbal Downers he didn't oh just a lot gotcha um no I'm just a tease of course so we have talked about the FDA before but yeah this is um this is a much more in-depth look that's right at the FT hey what's that you're Chris Walken no was that Chris Walken no not really I mean that the weird cause is but I was more doing Shatner Oh but I didn't go up yeah octave which I should have sure pretty good though huh yeah pretty clear yeah Bill Shatner so uh did you know most of this stuff um well I know that the FDA is is has a history of controversy of people saying uh you know you don't act fast enough we need these drugs to help people other than other people like stop acting so much exactly you're going too fast and rushing these things to market right exactly so it'sit's a bit of a tough thing to reconcile you know they're acknowledged they're in a tough spot they really are and um I think that's a good good caveat for disclaimer to put at the front of this because yeah it is a very controversial agency it's the first consumer protection agency in the United States ever yeah it's the oldest one and it's Coleman liberal or what have you but I think it is a very important agency to have oh I don't think that makes you liberal some people may say so what they don't think we should regulate anything in this country yeah there's people who think that like that FDA is just completely in the way of business it's a oh okay I see what you mean a fetter right that's a thing sure cuz unfettered they if you can be unfettered you can be fettered right but is there something that can fetter and would that be a fetter sure so it's a fetter that's a business or some in some people's mind um yeah I just think that you when you are talking about something as elemental as food or drugs and things we put into our bodies in the hopes that we will be have a greater well-being that you kind of do have to have a big kid on the block looking out for all the little kids well I mean I think when when big bucks are involved it's pretty clear that companies themselves probably aren't gonna like pull back on their profits in order to just be super safe like it has been proven throughout history that they'll generally want like err on the side of making the money you know you're a commie oh boy this is gonna be fun so okay now that we got that out of the way Chuck let's dig into the FDA because if you want to see whether or not you think the FDA is necessary all you have to do is go back to the days before the FDA which wasn't too terribly long ago I mean the FDA really only finds its origins and 1906 on paper it goes a little bit back before that till I think the Abraham Lincoln administration yeah who was a pinko himself let's climb in the Wayback Machine shall we oh yes man it smells like cat urine in here I know I well I took a little ride with LaRon in the wizard in that whoa sorry about that man how are they doing well they're doing great but um I forgot to bring a litter box oh yeah yeah there was an accident dress so here we are the wayback machine and we're going all the way back like you said to the times of Lincoln yeah and what he did he kind of kicked kicked the man I couldn't say that the other day in private no I want to say get the ball rolling and kick it off and I said kick the ball kick the ball rolling I said that the other day it's like twice it's okay so he wanted to kick the ball rolling and so I did a chemist named Charles Wetherill to analyze agricultural materials sniff them on the case yeah he slipped them on the case not off and said hey food and soil and fertilizer maybe look into that we have the new Department of Agriculture and then his successors Harvey Wiley and Peter Collier were the dudes who really kind of got things going in a like a serious way for the FDA well they saw like a real reason for an agency that was in charge of guarding safeguarding the purity of food and drugs that the America was ingesting they basically saw what was going on was like hey we might need to step in here because prior to this I mean we talked about it in our bizarre medical treatments episode I think what we were just talking about like little kids being given morphine yeah in like a prescription that in no way shape or form said there was morphine in it just calm colicky babies yeah and it calmed them by bringing them to the brink of death on a morphine overdose but you could buy it over the counter hey you shouldn't regulate that that's business right that's right that's what and that was the one that actually used morphine there I'm sure others that were out there that were much more lethal sure use knockoff morphine or something like that but cousin Tony made in his basement yeah you could do it or bollock bottle and if the person if the person bought it and they died well buyer beware yeah you know so the guys like why Lee and Collier especially Wiley though yeah we're really adamant about getting some sort of regulation and specifically taking this agency that they've been handed and and building it into into a real powerhouse yeah and over the course of about 25 years they got Congress to look over about a hundred bills for the food and drug industry right I guess Congress said no no we're pretty deep in the industry's pocket so we can't really do anything right now we agree with you yeah totally great idea but I'm sorry but I car is about to be invented and I want to own one pretty bad well that all changed though my friend in 1906 when reporter novelist Upton Sinclair wrote the jungle yeah which um like everyone sort of this very famous book that exposed the practices of the meatpacking industry yeah in Chicago in particular but um it was a big deal and it caused a lot of people to really freak out it wasn't it was a novel which means yes fictitious based on his and he was a journalist too yeah it was based on his experiences I guess working undercover in the Chicago meatpacking plants and apparently I guess Roosevelt Teddy Roosevelt set up an investigation a committee to investigate yeah he'll Ames maybe no fan of Sinclair's at all but I think he's sort of everyone was so repulsed he had to do something yeah I mean like it really got the American public up because the stories are things like they're using disease cows for meat and there were rats that were crawling around on the cows yeah and so they poison the rats and then the dead poisoned rats with the poison and the diseases to cow meat would all be put into a grinder and there was your potted meat on the other side yeah he was uh I still won't eat potted meat yeah well I don't care what year it hits you take me to the future in twenty-two thousand three hundred and twelve and I'm not gonna eat potted meat I wish the wayback machine could go to the future well that's the way forward machine oh we have one of those well Mel's working on it it'll be a while so they had to do something because there were even accusations of people being in meat which apparently was not true and that was really fictitious right but that committee that investigated Sinclair's claims in the jungle found that pretty much everything else he said in that book was true yeah step four the guy being ground up with the beef because he fell into a meat grinder and they were just like no all right again the meat business not able to police itself and say maybe we shouldn't put diseased rats and meat so the government was forced to step in and in 1906 on June 30th Congress passed the Food and Drugs Act aka the Wiley act and that prohibited trade of mislabeled and contaminated food bevies and medicines across state lines you know I guess he could still sell it into Illinois you know yeah that's the one thing I never get is the shipping thing like well it's the only thing that they can an enforcer well yeah the the federal government is there's always been a struggle between state Asia and federal right yeah and so the kind of line has been drawn at the state borders where it's like right across the state border all of a sudden you're part of the United States rather than just the state and you want to leave it up to the state but yeah over time the federal government has taken more and more power from the states right with the Wiley Act though Chuck I mean it's named after Wiley so it gives you an idea of like the links that this guy went to to to try to establish some sort of standards for purity and food right yeah one of the things he did was set up what came to be called the poison squad yeah that's a great name isn't it it really is and it was a sensational name and at first he fought it and then he finally saw like he was worried that with a name like the poison squad they had their own little poison squad anthem and yeah the articles written about the poison squad really sensational and like can you believe how crazy these guys are yeah and at first Wylie fought it because he he was like this is a really serious scientific undertaking and then finally saw the writing on the wall I was like you can get America behind this whole idea if you just give them the poison squad as they want the poison squad is like I have added everybody do they have an anthem they did it's in this this article from like the FDA's own consumer magazine or whatever from I think 2002 the poison squad the boy squad is something like something it's kind of like that it's like um it's like when they take these bites they won't feel any pain yeah but when they wake up in the morning they'll probably never be the same or just stuff like that it's kind of like um you know how they used to make jokey songs in the early 1900s interesting so what the poison squad was was a group of men volunteers we should point out who signed up for this and repeatedly signed up for this yeah and signed away their right to sue or anything they were fully on board to eat poison and to basically in a kitchen there on Washington DC in the basement of the FDA's building yeah they would had a chef that apparently made some great meals laced with all kinds of poison formaldehyde borax what was a really harmful one it was called copper sulfate right which is now pesticide correct yeah and they use it to make canned peas appear bright green and that that kind of gets to the heart of the matter Chuck like these guys weren't just eating poison just for fun oh no they were testing out stuff that was being used as preservatives food at the time exactly additives and preservatives and stuff like you said to make your peas greener right all right yeah so people used to use formaldehyde to preserve meat makes sense right people used to use borax against formaldehyde look how long that human heads been in that bucket exactly let's put it on beef so did you touch that head or did you just like sigh you know didn't poke it at the end of a mom I don't know it hit his face bobbed up at me and I was just like alright here it is good hello sir so the poison squad made great headway they they really determined a lot of stuff that shouldn't be used as preservatives like that copper sulfate that was used to make these green yeah national heroes in a way well yeah they also proved overall that selling adulterated food wasn't just a buyer beware kind of thing right that it actually posed a real public health hazard yeah they got super sick they did and that got publicized these guys are getting sick on purpose yeah from the same stuff that you're feeding your kids yeah which is why they shut it down eventually right and the public office is like well we don't want this stuff in our piece I don't care whether they're green and I'm not eating this and then public pressure led to finally Congress enacting the Food and Drug Act I wonder if I'm when I was reading this I was wondering if that has something to do with the the the thing with Pete's like I don't think people generally like Peas and I wonder if that has anything to do with it these are correct I like peas but I wonder if that was like a stigmata on the pea when this stuff came out you know have blood on its palms blood on its pee uh maybe I don't know I don't either surely it had some effect I would guess well it's like it probably a lot like how they spray produce in the produce section right even though it increases its rotting time dramatically why did I do that to make it look prettier to make it look fresh it's ridiculous but it's probably the same exact principle I bet you're right here's some poison to make your beef so the FDA when they formally evolved they evolved out of some other agencies they've been through a bunch of name changes and reorg through the years but in 1906 what they're they were under the Department of Agriculture's Bureau of chemistry and they were the ones charged with enforcing that Food and Drugs Act so they split them up in 1927 into two groups the Food and Drug insecticide administration they handle the regulations and the Bureau of chemistry and soils handled the experiments yeah before it had been just the Bureau of chemistry doing both yeah so they split them up eventually they dropped in 1930 the name insecticide and it just became the FDA yep and from there they were in under the guise or under the purview of several agencies till the late 70s and they finally landed where they are now which is the Health and Human Services that's right yeah HHS green peas so today the way they're organized loosely they're not working as loosely but this is a description site is this they have a top layer of the office of Commissioner of Food and Drugs write a report to the director of sorry the Secretary of HHS who used to be tommy Thompson really yeah under Bush oh that's right do you know who it is now I don't there's probably no one there Obama hasn't been able to get anybody confirmed like either term that first layer also has seven support supporting organizations that support the Commissioner and they're mainly on they're not like the rubber meets the road they're the on the policy side of things yeah basically litigation and stuff well yeah the the big step the big overarching we are the FDA yeah and then below them are broken down the in the components that handle rubber meets the road stuff yeah those are the five deputy commissioners and they're there like you said they're the ones that really are heading up the field offices I think there's four hundred I'm sorry 227 field offices and then they have their big home in Silver Spring Maryland where they have about close to 15,000 employees and Chuck let's do a quick quiz you ready yes okay the F balls no you gotta wait sorry that I know you're very excited right now he's hanging in there the FDA regulates true-or-false x-ray machines I'm gonna say true that's right they they regulate radioactive or radioactivity emitting machines like x-rays pesticides false that's right Chuck yeah oh that's the USDA from what I understand uh-huh illicit drugs cocaine and crack cocaine they don't regulate that no that's true they don't yes let's see what else what about donated blood true that's true they they regulate biologics yes great man in vaccines employed yeah thank you tobacco they do regulate that I believe yep and then what about poultry chicken yes of course they do no because it's food no USDA again although the FDA does regulate apparently the dairy industry yeah but not meat and poultry now talk about mind-boggling they do regulate cosmetics but obviously because we did a podcast on it uh-huh they don't regulate several supplements yeah that was a good one if I remember correctly we really like got to the heart of the matter yeah and there's a lot of and I think it talked about it then there's a lot of slippery language that can be used in body products period which always aggravates Emily to no end yeah because she has completely natural body products but you can throw names on packages these days on foods to that just say like pure and natural and oh yeah just these buzz words that mean nothing and there's no regulation for when you can use those words yeah and it's just it's they're trying to sell people on something that's not true yes it's really sad like light beer I remember hearing years and years and years ago that light beer only has to be light in colour to be called light beer really yeah but now that I'm grown I'm like oh but like who regulates that I'll bet you doesn't even have to be lighting color and light and color compared to what yeah you can probably call something light beer if you want to well it's like in calories right buyer beware but your point is it's not regulated right probably not a beer has to be under this many calories to be called a lot yeah I don't believe it is and now I think I would probably be the FTC that would be in charge of that kind of thing but they get bigger or that ATF yeah man the government sure just have a lot of lettered agencies yeah one last thing about the FDA though there's a group of special agents in the criminal unit that carried guns really FDA agents that carry guns and will shoot you but will for doing what I've got a great example of it okay had they caught whoever it was that poisoned the Chicago area tylenol in 1982 big probably would have shot that person yeah yep do you know about that do you want to talk about that now sure might as well huh yeah I remember this I do too man yeah I was a six-year-old whose eyes were just opening to the ideas he poisoned drugs and learning to fear things that you bought at the store yeah I didn't I don't I didn't know the specifics because I was only 11 and I never lived like researched further as an adult but 12 year-old girl died in suburban Chicago after taking tylenol laced with cyanide yes it turns out right she was dead by the next day I believe no a couple hours Oh a couple of she took it that morning then yeah at 7 a.m. 7 a.m. so uh that same day a 27 year old named Adam Janis of suburban Chicago died and then his brother and sister were consoling the family they thought it was a heart attack we're consoling the family and just sort of doing the post death family stuff very stressed got headaches they took tylenol and they both died yeah I had no idea that connection three more people died over the next couple of days all from they found out upon investigating all of them had taken tylenol right before they died yeah so they started right yeah they started looking into it and it turned out that there was poisoned tylenol in the Chicago area yeah and everyone freaked out because at the time tylenol was like that was it sure you had an over-the-counter pain reliever it was tylenol yeah and they didn't have tamper resistant bottles at the time what they later figured out is that somebody bought tylenol took it home I guess laced it with cyanide and then brought it back it made it look like it had been unopened yeah and people bought them and died from they still don't know who did it they made it look like it was unopened by just closing the lid again right because again no tamper resistant packaging right until this right this changed everything so the company that makes tylenol under Johnson & Johnson like issues like a national media alert that said like everybody should probably stop taking tylenol and send us your yeah I went on we'll send you new stuff that we know is good but don't think I'll which is kind of cool for a company yeah they really like I mean they had no choice I think but the super go on the offensive with this yeah and it's actually due to Johnson and Johnson it wasn't the FDA saying hey we need to get tamper resistant packaging Johnson & Johnson actually said hey I think we should start investigating tamper resistant packaging right so they sort of led the charge yeah and then in cotton in 1983 Congress said let's make tampering with medicine a federal crime yes and then just just six years later the FDA said let's make these awesome tamper resistant bottles yeah mandatory you know don't know why it took six years to do that I'm talking about a federal bureaucracy here now but it seems like that something could have sped through just like me right but uh anyway 1989 is when that's why it's so hard to get into pill bottles these days thankfully yeah little foil coatings and all that stuff that makes doesn't mean you can't open it but it means you will know if someone has opened it yes you know like if you buy it and you're like wait a minute that foil is poked through by a human thumb right I can see it glowing yeah tylenol it's not supposed to glow all right so let's take a break okay and after this we'll talk a little bit more about how they regulate stop you should know I'm gonna make an offer he can't refuse bone oh you built the time machine out of a DeLorean everybody this is Chuck from stuff you should know and if he didn't guess that was me doing bad impressions to talk about my new show movie crush it releases every Friday on Apple podcast or wherever you get your podcast and each week I sit down with an awesome person to talk about their favorite movie go check it out if you love movies if you love great conversations you get a love movie crush so how does well first of all how much do they regulate and the answer is a ton of products yeah some estimates say that 20 cents out of every dollar consumers spend and that's on everything TVs you know VCRs right that ta doesn't regulate satellite dishes laser discs all the money that we spend on everything 20 cents out of every dollar we spend is on a product that's regulated by the FDA it comes under their purview yeah which means you have too much to do supposedly that equals about what they they regulate about 1 trillion dollars worth of goods and services well goods yeah all right so they regulate we already talked about what they do regulate they also also offer guidance at times on maybe how advice on how regulation should be carried out so that's one of their tasks as well right like maybe you guys should make your pill bottles tamper resistant right our criminal enforcement unit isn't going to come shoot you if you don't because this is a guideline right but now that it's 1989 now it's mandatory yeah or they may visit you they do about 16,000 facility inspections per year everything from dairy farms to blood banks but that like we said they're way more facilities than they have field workers so I think they you do they well they use the element of surprise sure or the potential the element of potential surprise right so surprise inspection surprise visits yeah I I hope hope hope and I'm pretty sure that the FDA doesn't call and schedule inspections ahead of time right if they do then then write your congressperson and make sure that this gets changed immediately yeah because they can't we're talking 14,000 employees in total yeah not just inspectors in total for all the FDA oh yeah less than 15,000 people are in charge of not only visiting factories and dairies and places that that use x-ray machine and all this stuff all the things that they regulate yeah not just in the US but like in other countries too how they do yeah they just set up their first office in Beijing in the last decade or so yeah because they have to they have to watch what's coming into the country as well because Americans don't just ingest American products yeah I mean just products for overseas and those things have to they have to follow the same guidelines as any other product that sold or solar used in America because the FDA's jurisdiction isn't stuff that's made in America right Duff that is consumed in America yeah I guess I just thought that would be maybe the FTC or something but not imagine they all kind of work hand in hand to get the job done they'll quietly hold hands while they do their research and how do they do this they do it because they are funded to the tune of 4.4 billion dollars about 2.6 of that comes from the Treasury and in other words your tax dollars and the remaining close to 2 billion comes from user fees which are very very controversial you want to talk about the user fees yeah so the before what was it 1992 I believe I think so the the FDA was fully funded by taxpayer dollars yeah all of its funding from the Treasury yeah and then in 1992 Congress passed a law that said the the FDA can start generating its own revenue by accepting user fees yeah the Prescription Drug User Fee Act right so in that act it says if you are a prescription drug company a pharmaceutical company and you want to have your your drug examined by the FDA and in a lot of cases most cases you have to have it submitted for review by the FDA sure you also have to pay a fee call it an application fee call it a user fee what have you well there are many different fees right so call that let's say you want to get your drug fast-tracked you can pay an exorbitant fee yeah and we'll put it at the top of the pile even yeah and so all of a sudden now chuckers the FDA is not policing the pharmaceutical companies any longer it is servicing the pharmaceutical companies yeah and the pharmaceutical companies as of 1992 became the FDA's clients yeah that was really really bad as far as consumer protection goes yeah and there are many different ways of looking at this one is that way which is that the the pharma lobby is writing checks to the FDA to the tune of billions of dollars and that can't be good right right the FDA that I've read this great article on PBS where they just interviewed a bunch of people for a variety of opinions yeah it was very balanced it was very fair and balanced not like us it's bad they the FDA's rebuttal will look a little something like this what what it's done is it's really helped us out we've increased our productivity by close to 80 percent we've been able to hire so many more people which means we can regulate so much more it's really helped us in the review process right the pharma lobby says this is great because it gets things going super quickly right it's very efficient and it's not fettering yeah and it hasn't changed the review process has just made things faster and we can get these drugs to people quicker because people need these yeah so there's a lot of different ways of looking at it if you ask Raymond Woosley who was he was up for he was the vice president of Health Sciences at University of Arizona I think this was in like 2002 he was up for commish of the FDA he's he's a safety guy yeah he was rejected and he flat out said in an interview like it's pretty clear that people that really care about drug safety will never get this job again right the Commissioner of the FDA and he said it's a great sadness to me that people who care about drug safety and food safety to the level that they get involved they try to make a difference and can't be accepted to regulate the agency and he said for me it should be protection first and then serving second serving meaning the industry right and that's sort of not the way it's gone since the user fees have been introduced yeah from from the research that we've done it seems like every critic of the FDA from all walks of life in all stripes points to that user fee as possibly the number-one problem yeah well as far as coziness between industry and the agency that their funding regulates yeah makes total sense you want to separate those two things generally and then the other problem is funding for the FDA itself that it is a grossly underfunded agency yeah for what its test with doing so it does have to rely on those user fees whereas I think it's a lot like campaign finance reform yeah where if you could just take that and replace it with public money then you can you can separate these two things that aren't supposed to be cozy with one another that a government agency that's not supposed to rely financially on the industry that it's regulating yeah and I know you want to do a show on lobbying soon that's uh that's gonna be a firestorm it is we're gonna be sitting there like gripping the table the whole time well what you mentioned though how they're funded though it's interesting I think until recently the way the money was even divided like how the budget money was spent was pretty hinking because you couldn't even use any of that user fee money to regulate safety at all although that had to go unto the service side of things right I think now they are starting to to be able to use that money for safety as well yeah but I think that's not happening fast enough for people that are truly concerned about the safety of our country and there is this I think I sent it to you there's this Forbes article from 2014 about a year ago there was a Yale study that came out that really just raked the FDA over the coals and it was a analysis of a bunch of different FDA approvals from 2005 to 2012 yeah publicly published right stuff it's not like they had to dig in right they just went and did an analysis of it and they found that these FDA studies were all over the place as far as the data they accepted yeah what what cleared and what didn't the sample size how long trials went on yeah and the it was basically used to publicly shame the FDA saying like you guys aren't even using good science aren't even trying to keep up this pretense right that you're following your own standards or that you even have steered you guys you're just rubber stamping pharmaceuticals and to kind of give an opposing point of view this guy on Forbes said well wait a minute like this is totally unfair because the FDA's actually what they're being criticized for here is actually its certain kind of nimbleness that the end-user the patients who are taking these drugs really want yeah so they're saying for something that's a really huge sweeping drug that's going to be used by a lot of people like a large drug right there they they should and typically do follow some pretty stringent guidelines they have to have a huge population sample they have to carry these studies out for years yeah and they require a lot of really good data but if you have something that is like a really obscure disease or a drug that treats are really obscured is like more more gallant sure they are going to accept this data that used a population size of like a hundred people yeah because there's just not that many people out there with this disease and it may be a shorter live study because if it's a really fatal disease these people want this drug and to get it out the door yeah quicker and there may only be the one study you may not have to do Rennick ate it and replicate it three or four times so he did a good job of like presenting the the other casing really pointing out how the FDA is very typically it's it's in a damned if you do damned if you don't situation yeah on a daily basis because in that same study that found you know that they it will accept a population of 100 in a study and it goes out the door very quickly in the approval process happens fast in that yeah since on the other hand when the FDA doesn't do that and really takes its time and digs in and studies it gets accused of basically just letting people die which was the case with the advent of AIDS yeah eighty sure HIV drugs were being tested and people in the HIV community and and at large in the country we're saying advocates were saying hey people are dying and like these drugs are very promising like let us try them out and so I do get it man like they've been accused of dragging their feet going too fast and finding a happy medium or I think I don't know I don't know if it's a happy medium or if it's you should only strive for safety and if it takes too long it takes too long or if it is super quick it's super quick yeah like Safety's should be the most important thing and it doesn't seem like that that's the case no it should be the most important thing but at the same time there should also be an awareness of you know what's going on outside the doors of the lab there are people dying yeah you want a safe drug but also if you have people are saying like remember with the Ebola outbreak there people are like I will die from this drug I will sign whatever you need just give me the yeah let me try it right and they they went ahead and and let people use unapproved drugs it's like the poison squad almost these people were volunteering right willfully volunteering so well they were also dying of Ebola at the time well yeah those sure um the poison squad were totally healthy yeah so they joined the poison school right yeah did you know also the poison squad it was a very scientific study the guys were not allowed to eat or drink anything outside of this dining room yeah except for water they had to turn on all their poo and pee all of it all of it not a drop or a speck was allowed to go unmeasured in on a not a drop no skid mark but the that the FDA and AIDS activists collision from the early eighties have you seen how to survive a plague no great documentary yeah but the the documentary deals in part with that and it's really really interesting and that was actually scored the soundtrack was scored by our friends superhuman happiness oh nice listen to this show hey guys good for them yeah so go see it it's a very good good documentary I will check it out is that on the old red streaming service yes I'm sure it's on I'm sure it is called something like Netflix that's that's exactly what it's called okay you're confusing me Chuck all right so let's take another break here and when we come back we'll talk a little bit more about some of the various successes and failures of the FDA hi this is john roderick from the rock band the long winters and I'm Ken Jennings I'm a writer and former jeopardy genius what why do you get to be two things that I'm only one thing because I'm twice as accomplished as you I left things out John that's so not true we have a podcast now called omnibus I'm nervous is gonna be launching on December 7 oh well that was a day that formerly lived in him for me and now is a day of rejoicing we are taking it back new episodes will follow thereafter on not infamous days every Tuesday and Thursday listen on Apple podcasts or wherever you get your podcasts whether that's at the grocery store or see them laying on the side of the street we're not gonna judge them if they hang over our telephone wires like shoes you just make sure you subscribe so you never miss an episode that's right subscribe listen to me now so you never miss an episode all right um can we talk about this Harvard paper yeah this is from an article titled risky drugs : why the FDA cannot be trusted boom boom and it was basically about a paper published in the Journal of law medicine and ethics from Harvard University where they contend that they present evidence actually that ninety percent roughly of all new drugs approved by the FDA over the past thirty years are little or no more effective for patients than existing drugs they're saying it's they still beat placebo typically yeah well they're saying is like all these new drugs aren't any better than the old drugs there's this competition on an already saturated market exactly so it's like why put the FDA through that if they're already overstretched then why can't those resources be allocated to something else that it's dropping the ball on right sure and they also you know try to make a point about the the safety level of these drugs that we are taking when they point out things like every week every week 53,000 hospitalizations occur and 2400 deaths occur every week in the US because of people taking properly prescribed drugs to be healthier so that's just a bad reaction to it a an approved drug that's how I read it and I'm reading that wrong one in five drugs approved ends up causing serious harm while one in ten provide a benefit compared to existing established so that's the 10% so the data is then this is what this Harvard paper is saying it's saying that yes one in ten drugs that comes onto the market the FDA's approved is it provides a benefit that no other drug does so in the past 30 years which i think and now that i've kind of make a connection with something else another article that that they were really touting like there's no other drug like this this provides a benefit that other drugs don't right so I think that's a big like buzz word it provides other benefits right but one in five of those drugs will go on to cause some sort of harm right that's crazy yeah and the they go on to say in that paper that the FDA they feel lends credibility to widening and lowering criteria for prescribing drugs what they call the selling of sickness and what you're talking about like a new and improved drug basically drug companies are raising prices from ear to ear on the same drug and they said we're the only country in the world that allows a drug to have its price increase without showing like here's why here's the benefit here's why it's improved and here's why it costs more and apparently the US is all in country that does that so Wow yeah if you want to UM read that article really all the articles we've mentioned you can go to our podcast page on stuff you should know calm the part of the page for this episode it's got all the additional links yeah I'm glad we're doing that now I think that's good yeah it's definitely open things up for the truly curious yeah you really want to dig in baby we got it for you can we talk about antibiotics and livestock yeah this is a big one you found this in the Atlantic right yeah and this is a big I mean it's just a big issue these days period about what is going into the meat and that people are eating like in factory farms and stuff the FDA in 1977 basically said we're not gonna put antibiotics in livestock because it's dangerous and just in 2012 they filed papers in court that acknowledged that they weren't safe it says more studies a series of additional studies were conducted by other government agencies and non-governmental organizations during the 90s all of which generally support the FDA's concern regarding public health threat posed by antimicrobial resistance yes so what happens is you you give healthy livestock otherwise healthy livestock antibiotics in their food right because the the living conditions are basically ripe for an epidemic yeah or it helps them grow faster right so but if they're on antibiotics they stay healthy despite these in conditions well the problem is is the bugs that these antibiotics are fighting off develop resistance to the antibiotics right and they can some of which are zoonotic these bugs and so they leap from say cattle to humans and they're already resistant to our antibiotics that we've been giving healthy cows so now you have an antibiotic resistant super bug yeah and that's a really dangerous thing and what you've just said is but since the 70s the FDA has publicly said that this is dangerous and it should should not go on any longer but they still they didn't do anything about it now they're their tack right now is to say that the livestock industry can police itself it doesn't seem like that's happening but that is their position at this point and this is why you see a lot of meats now in your store that say antibiotic free it's like a big selling point because right even like you said even the FDA says really dangerous yeah but they just haven't enacted any law about that although they have that's not entirely true they have listed some antibiotics that I know they called out one in the article that said you can't use this one right but apparently it's only used in like 0.25 or it's only yeah point two five guessing of all antibiotic cephalosporins yeah so people that are you know want to live more purely or saying they're not taking enough efforts I mean they were sued by the National Resources Defense Council saying you have to take action on this well in that say I'd protect us that that it takes the courts to force a government agency to protect consumers in that way in a way that the agency itself is saying like yes this is dangerous yes somebody should do something who will do something and then everybody's like well it's kind of your job to do that and they're like oh don't worry about it that's fine yeah I mean they actually the FDA pulled public notices at the federal register that had been around for 30 years they literally just made them disappear overnight yeah when this became controversial in the 2010s they just said we're gonna take the that those briefs where we said that it's dangerous and somebody should do something we're gonna stop having those published right they also were largely criticized a few years back for basically like just sitting on their hands about the GMO labeling yeah yeah that's a yeah dan quayle kind of changed history with that many years ago what did he do I think he was the one that pushed for the legislation that allowed GMOs okay so this is fine you got GMOs you got a label food that contains GMOs right that's it don't do anything else you just have to say on the label this product may contain GMOs right there was a big push apparently a million signatures were were generated from the just label at campaign yeah and were submitted properly to the FDA and the FDA rejected all but three hundred and ninety four of the signatures that were given to it because about a million of them were in a single electronic document and they were like these don't count Wow so they didn't do anything about it and there's still no GMO labeling so regardless of how you feel about GMOs and GMO labeling that's pretty shady stuff sure just overtly reject a million signatures especially as part of a large national public campaign oh yeah absolutely Vioxx is a painkiller that was approved by the FDA in 1999 and it was fun by the way a to just to cover this stuff yeah in 2000 a study showed that the drug posed a big heart attack risk when compared to a similar painkiller and merck who was a manufacturer by ox kind of blew it off and said it's really beneficial in the fda said okay and by extremely much our Vioxx remained on the market for another four years and they estimate between 88,000 and 140,000 heart attacks were caused by Vioxx in that time and it was it wasn't that DEA whoever removed Vioxx it was mark bowing to public pressure oft had never known Everdeen Merck just took it off the market itself because it was starting to look bad and the FDA was like what's going on what are you guys doing how about a success in the 1950s in Germany there were scientists who created something called thalidomide which was a sleeping pill right and they said it can't it's over the counter it's totally safe all over Europe for pregnant women even yeah is the sleeping pill not so safe though because children were being born with malformed limbs to the tune of ten thousand worldwide but not very many in the United States because Francis Oldham Kelsey of the FDA was really resistant and made a big push to not allow the Lydda Mike's she didn't think I'm safe no she was in charge of reviewing the data and said what is this this is basically anecdotal like where's your real data yeah and would not withstood a lot of pressure to approve this drug and would not cave in and as a result only 17 babies were born with malformations yeah because of the little US in the US and the whole reason that there were any was because they found out the drug maker was pushing the drugs for free onto American doctors to distribute as samples while theirs while the FDA was holding up approval and so seventeen children were born with deformities because of it yeah because of this for these free drugs apparently in Canada the story was even different the Canadian government it was totally it was totally legal and approved in Canada yeah and four months after it became worldwide known that thalidomide caused birth defects because it crosses the placental barrier right and arrests development of the fetus right Canada knew everybody knew about it and it took months before Canada finally outlawed it so there's like this real big public shame hanging over Canada's government agency of regulating drugs Wow still to this day because of that and Billy Joel wrote a song about it oh yeah well it was in that a terrible thought we didn't start oh yeah oh my yeah I forgot about that but yeah that was one of the FDA's great successes and as a result actually the Congress passed something a an amendment to the Food and Drug Act the Kefauver Harris amendments in 1962 that really expanded the FDA's scope of duties it put you know how you know those have drug ads have all those disclaimers area that's from the 1962 amendments advertising is under the Jersey seems like a they read those so fast and the last one is an early death right like they need to say early death hey no they am prior to 1962 the FDA had 60 days to respond yeah to an application and if they didn't get to it in time well that's fine I'm sure it's fine you can go to market that changed to I think a hundred and eighty days and it's just to respond and then also drug makers only had to demonstrate that their drug was safe not effective that changed in 1962 as well yep they also said that they had to control the marketing of generic drugs to keep them from being sold as just like jacking up the price under a new name basically so um yeah that was a great amendment the curfuffle harris amendment is that right Kefauver uh-oh Kefauver that's this Kefauver so another great success yeah well that was the same way well no I mean in addition to the lid mine gotcha and then in the news recently you dug this up the Zohydro painkiller you didn't hear about this no I haven't heard of this until today it's apparently it's pure oxycodone correct it is there's the first time yeah there is um all the other stuff like vicodin and oxycontin even are far safer because they contain at least something else like acetaminophen or some other drug yeah this is just pure hydrocodone and you remember like there was a huge huge problem with pill addiction to oxycontin in particular yeah it wasn't just rush limbaugh a lot of people yeah we're really hooked on oxycontin as a matter of fact the current hair an addiction crisis in the u.s. is a direct result of the FDA stepping in and saying like hey you guys need to do something with oxycontin like people are crushing it up and injecting it you got to do something so I'll just do heroin there's well there's a tamper-resistant thing where when you crush up oxycontin now it turns into this goo that you can inject or snort right can you lick it off a mirror you can I guess but I don't think it has the same effect right because when you when you crush it up it was time release and when you crush it up it's not time release anymore it's like all there to give you this immediate drug abusers will often do right so now that when you crush up oxycontin it turns into a goo everybody's turn to heroin right so now there's a heroin epidemic this company makings Oh Hydra came along and said well let's Cole just release this completely pure hydrocodone pill without any tamper resistance so we're gonna go back to square one everybody okay and there was a huge outcry against this drug and the FDA had stepped up and became a mouthpiece for it yeah and the FDA will they will defend it the decision by saying while putting things like acetaminophen has well-known liver damage risk okay this is actually more pure you can actually take hydrocodone now people in severe pain can take this drug without that liver toxicity risk but I mean that's the point no it is a point and if you're in severe pain in life and need this to to function or live out your life then great but that make a tamper-resistant hot about what people are arguing about they're saying that this is a very high level for abuse right because there's no tamper resistant yeah exactly so people are going to die because of this drug yeah I think in 2010 prescription hydrocodone and other prescription opiates accounted for almost 17,000 deaths which is a four-fold increase from just 10 or 11 years earlier right and that was all OC before they made it tamper resistant Orange County there's probably a lot of it in Orange County I bet there is so there you go crazy stuff it is crazy stuff I kind of am with that professor from Arizona that's just like safety like it's sad that the chief of that organization can't be someone who's super Pro safety above all else yeah their that's their job there's such a tug of war between the public and I guess corporations over safety yeah and the FDA is not pulling on our side necessarily yeah and I'm sure we'll hear from all kinds of people from the pharmaceutical industry that will tout how seriously they take their testing and stuff and we're not saying they don't no no but um no I think it is a there are great protocols and seizures and procedures but there's also plenty of times where they just overtly drop the ball yeah and Public Safety suffered as a result agreed if you wanna know more about the FDA you can go to the FDA website fda.gov you can go to how stuff works : in the search bar don't forget to go to our podcast page on stuff you should know calm for the FDA episode that you're listening to now and since I said search barn there somewhere it's time for listener mail I'm gonna call this we inspired a writer awesome hey guys and Jerry first off thank you so much for what you do have been a fan for over three years steadily working my way through the backlog living in constant fear of the existential dread that will settle upon me the day I finish I my sister as well and whereas our conversations used to be 100% simpsons quotes now it is 90% Simpsons 10% stuff you should know that's a high honor she says but I digress I'm writing because I'm an author of dark humor novels for young adults and I wanted to express how helpful your podcast has been with inspiring and informing various elements of my books for example the one I'm currently writing is about a creepy candle factory in a creepy small town with a big creepy mountain where in back sculptures come to life and after listening to your earwax episode Mount cerumen was born pretty neat ever since the haunted house episode I've been itching to write a horror about a horror attraction that goes terribly and hilariously wrong number stations equals something awesome and so on and so on so we're inspiring her all over the place right I never know where your inspirations gonna come from but you show provides me with a steady stream of delicious possibilities I want to thank you the best way I could so I named a couple of off-screen highschool characters after you guys in my most recently published book hellhole so wait how about that that is a huge honor pretty neat and she's gonna send us some copies and one for Jerry to of course she says so I'm gonna send our mailing address and thank you she says thanks for the brain snacks and that was from Gina D'Amico da mi Co and she has a website you can check out her kind of a weird funny twisted young adult novels at her site and support support writing yeah creativity Thanks like do you know right yeah and make sure you get L old so you can see our names in print you don't like agency that was a waiting for Guffman joke Oh was it mm-hm oh you'll explain to me later right how are you

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